BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 15658217 · Received October 24, 2022

    Report

    Report Number
    3003152976-2022-00470
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 29, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 13-DEC-2022. THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE BARREL WAS OBSERVED TO BE DAMAGED, VERIFYING THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110020, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING THE MARKING PROCESS, IT WAS IDENTIFIED THE MARKING MACHINE WAS PERIODICALLY CAUSING DAMAGE TO THE PRODUCT AS OBSERVED IN THE SAMPLE PROVIDED. A PROJECT WAS IMMEDIATELY INITIATED TO RESOLVE THE ISSUE, REPLACING PARTS WITHIN THE MARKING MACHINE AND IMPROVED INSPECTIONS WERE PERFORMED, AS WELL AS INCREASING INSPECTION FREQUENCIES TO BETTER IDENTIFY IMPACTED PRODUCT. BASED ON OUR INVESTIGATION IT WAS DETERMINED THIS INCIDENT IS RELATED TO THE ISSUE IDENTIFIED DURING MANUFACTURING, THIS SAMPLE NOT BEING PROPERLY IDENTIFIED AND DISCARDED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ SYRINGES EXPERIENCED DEVICE DAMAGE WHILE CONSIDERED OPERABLE, AND LEAKAGE PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING SYRINGES. LIQUID LEAKING PAST PLUNGER. THE BARRELS APPEAR TO BE SLIGHTLY BUCKLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ SYRINGES EXPERIENCED DEVICE DAMAGE WHILE CONSIDERED OPERABLE, AND LEAKAGE PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING SYRINGES. LIQUID LEAKING PAST PLUNGER. THE BARRELS APPEAR TO BE SLIGHTLY BUCKLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821594 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown